Method of orthopedic treatment by radiation

ABSTRACT

An orthopedic infra-red laser medical device and methods of use for applying infra-red energy to an anatomic region of interest located within the body of a patient. The device includes a hollow needle and a housing on which the needle is releasably mounted. The housing includes an infra-red laser source for producing a laser beam and directing the beam through the needle to exit out of the open distal end of the needle. The distal end of the needle is sharp to pierce through the skin of the patient to a position closely adjacent the anatomic region of interest to deliver the infra-red laser beam thereto without any intervening skin and tissue attenuating the infra-red laser beam. The device can be used for various orthopedic purposes and can also be used on fat in a patient to release activated stem cells.

CROSS-REFERENCE TO RELATED APPLICATIONS

This continuation application claims the benefit under 35 U.S.C. §120 ofapplication Ser. No. 14/861,067 filed on Sep. 22, 2015, entitled Methodof Orthopedic Treatment by Radiation, which in turn is a divisionalapplication which claims the benefit under 35 U.S.C. §121 of applicationSer. No. 13/919,361 filed on Jun. 17, 2013 entitled Orthopedic Infra-redLaser Medical Device and Methods of Use. The entire disclosures of theseapplications are incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates generally to medical devices and methods of useand more particularly to infra-red (IR) laser devices and methods of usefor treating orthopedic diseases and conditions.

BACKGROUND OF THE INVENTION

It is well established that Infra-red has many benefits to the humanbody and there are many clinics that use infra-red for treatment ofaging process and its related complications. The problem is thatinfra-red cannot penetrate deep tissues. Thus, historically its main usefor therapeutic purposes has been directed to skin and the very nearsubcutaneous tissues

Recently, the introduction of pulsed infra-red laser that can penetratedeeper tissues for approximately three inches has enabled the treatmentof chronic pain. Moreover, some centres in the United States and Canadahave claimed that pulsed infra-red laser treatment can successfullyreplace some surgical interventions in many painful and refractorydiseases. Although this new advanced technique helps many patients, theskin still consumes about 50% of the beam energy so that tissues andstructures deeper than three inches cannot get good benefit from thePulsed IF therapy.

Thus, a need exists to provide infra-red radiation to deepertissues/structures, e.g., the back of lumbar discs or a mid-femurfracture, with good concentration for viable therapeutic results andwithout damaging the skin, i.e., exceeding what is called the skintolerance limit.

The subject invention addresses those needs.

The patent literature includes disclosures of some infra-red devices fortreating some medical conditions by delivering the infra-red radiationthrough a cannula into the body of a patient. Examples of such prior artdevices are shown in U.S. Published Patent App. Nos. 2012/0289859(Nicoson et al.) and in European Patent App. No. EP 2 449 994.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention there is provided aninfra-red laser device for applying infra-red energy to an anatomicregion of interest located within the body of a patient. The devicebasically comprises a housing and a needle. The needle is an elongatedmember having a proximal end, a sharpened distal end and a hollowpassageway extending therethrough from the proximal end to the distalend. The housing comprising an infra-red laser source located therein.The infra-red laser source is arranged when activated to produce acollimated infra-red laser beam. The needle is secured to the housing,whereupon the infra-red laser beam produced by the infra-red lasersource when activated enters into the hollow passageway at the proximalend of the needle and passes therethrough to exit the distal end of theneedle. The distal end of the needle is arranged to pierce through theskin of the patient to a position closely adjacent the anatomic regionof interest to directly deliver the infra-red laser beam thereto withoutany intervening skin and tissue attenuating the infra-red laser beam.

In accordance with one aspect of the invention the Near Infra-red (NIF)laser beam is a continuous beam in the range of approximately 0.7 μm to3.0 μm.

In accordance with another aspect of the invention the Far Infra-red(FIF) laser beam in a continuous beam in the range of approximately 50μm to 1000 μm.

Another aspect of this invention entails methods of treating anorthopedic disease or condition of a patient by the irradiation of ananatomic region of interest located within the body of the patient. Suchmethods basically entail providing a device like described above andintroducing the needle of that device into the body of the patient,whereupon the distal end of the needle is located closely adjacent thesitus of the anatomic region of interest. The laser source can then beactivated to produce the collimated infra-red laser beam, whereupon theinfra-red laser beam exits the distal end of the needle to impinge theanatomic region of interest without the intervening skin and underlyingtissue attenuating the infra-red laser beam.

The methods of this invention can be used to treat any of the followingorthopedic diseases or conditions: osteomyelitis, avascular necrosis,supraspinatus tendinitis, Patelofemoral maltracking, low back pain,delayed healing of a bone fracture, carpal tunnel syndrome, Planterfasciitis, Osteo-arthritis, and Coccydynia.

DESCRIPTION OF THE DRAWING

FIG. 1 is an isometric view of one exemplary infra-red laser device,e.g., a hand-holdable device, constructed in accordance with thisinvention for producing an infra-red laser beam to carry out the variousmethods of this invention in patients;

FIG. 2 is an exploded isometric view, partially in section, of theexemplary infra-red laser device shown in FIG. 1;

FIG. 3 is an illustration, partially in section, of the exemplaryinfra-red laser device of FIG. 1 shown in the process of treating anon-union or delayed union bone fracture in accordance with oneexemplary method of this invention;

FIG. 4 is an illustration, partially in section, of the exemplaryinfra-red laser device of FIG. 1 in the process of treating avascularnecrosis in accordance with another exemplary method of this invention;

FIG. 5 is an illustration, partially in section, of the exemplaryinfra-red laser device of FIG. 1 in the process of treating chronic lowback pain in accordance with another exemplary method of this invention;

FIG. 6 is an illustration, partially in section, of the device shown inFIG. 1 in the process of treating plantar fasciitis in accordance withanother exemplary method of this invention;

FIG. 7 is an illustration, partially in section, of the device shown inFIG. 1 in the process of treating Osteo-myelitis in accordance withanother exemplary method of this invention;

FIG. 8 is an illustration, partially in section, of the device shown inFIG. 1 in the process of treating supra-spinatus tendonitis inaccordance with another exemplary method of this invention;

FIG. 9 is an illustration, partially in section, of the device shown inFIG. 1 in the process of treating patello-femoral maltracking inaccordance with another exemplary method of this invention;

FIG. 10 is an illustration, partially in section, of the device shown inFIG. 1 in the process of treating Coccydynia in accordance with anotherexemplary method of this invention;

FIG. 11A is a reduced size illustration of the device shown in FIG. 1 inthe process of treating carpal tunnel syndrome in accordance withanother exemplary method of this invention;

FIG. 11B is a larger size illustration, partially in section, of thedevice shown in FIG. 11A in the process of treating carpal tunnelsyndrome in accordance with another exemplary method of this invention;

FIG. 12 is an illustration, partially in section, of the device shown inFIG. 1 in the process of treating Osteo-arthritic joint disease inaccordance with another exemplary method of this invention; and

FIG. 13 is an illustration, partially in section, of the device shown inFIG. 1 in the process of reducing fat in accordance with anotherexemplary method of this invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the various figures of the drawing wherein likereference characters refer to like parts, there is shown in FIG. 1 at 20an infra-red laser device constructed in accordance with one exemplaryembodiment of this invention and which can be used for carrying any ofthe methods of this invention. With respect to those methods, it must bepointed out that this application describes various exemplary orthopedicdiseases or conditions that the subject invention is directed to. Thosediseases or conditions are only exemplary. Thus, other infra-red laserdevices and methods of use are also contemplated and deemed covered bythe subject invention.

Before describing the details of the device 20 and methods of thisinvention a brief summary of the infra-red technology insofar as itsclinic effect is in order. To that end, as is known, there are threebasic types of infra-red radiation, namely: Far Infra-red (FIR), Midinfra-red (MIR), and Near infra-red (NIR). FIR ranges in wavelength fromapproximately 50 μm to approximately 1000 μm. It stimulates Mesenchymalcells (MSCs). Such stem cells can regenerate tissues. Recent studiespublished indicate that active MSCs can help in re-setting the humanbody system to its default baseline. This is basis for stem cellsinjection. MIR ranges in wavelength from approximately 3 μm toapproximately 50 μm. MIR apparently has no any clinical significance.NIR has a wavelength in range of approximately 0.7 μm to approximately 3and constitutes the shortest wave length of infra-red radiation. NIR canbe absorbed by pigmented structures of human bodies includinghemoglobin, chromosomes of the nucleus, and cytochrome oxidase enzymesof the mitochondria.

Infra-red radiation has several benefits at the cellular or molecularlevel. For example, FIR facilitates new bone formation. In particular,FIR stimulates RUNX2 (a transcription factor for MSCs of bone marrowwhich leads to new bone formation). Such activity is very important forelderly person because many of them suffer from osteoporosis andconcomitant reduction of bone mass, thereby rendering them moresusceptible to fracture with mild trauma. Pulsed FIR delivered fromoutside the body has also been used for reducing fat in the abdomen andfor harvesting abdominal fat (which is rich in MSCs) so that it can bere-injected into the patient's face to reduce wrinkles by the action ofMSCs in regenerating facial tissue.

It is believed that the release and activation of MSCs from deeper lyingabdominal fat by the application of infra-red radiation thereto offersthe possibility causing the activated MSCs to circulate in the bloodstream for deposit in every organ of human body, thereby allowingregeneration of every organ of human body with subsequent loss of largepart of abdominal fat. It is well known that abdominal fat exerts amarked stress on the joints of spine, the pelvis and lower limbsaccelerating their degenerative changes. Therefore, reduction ofabdominal fat indirectly reduces degenerative changes of the joints.

However, as noted above, the main drawback of such action is the skinbarrier that consumes 50% of the applied IR energy. Thus, to beeffective in the IR dosage applied from an external IR laser sourcewould have to be significantly greater, which could damage theintervening skin. The subject invention overcomes this drawback viaby-passing the skin, subcutaneous, and muscles barriers.

NIR laser radiation is absorbed by pigmented structures, e.g.,hemoglobin, chromosomes of the nucleus, and cyto-chrome oxidase enzymeof inner membrane of the mitochondria. This results in various benefitsof NIR. One benefit is as an anti-oxidant. In particular, externallyapplied NIR laser radiation is absorbed by cytochrome oxidase which isresponsible for energy production by the mitochondria in the form ofATPs particles. As is known, ATPs are the chemical structures of storedenergy inside human cells. This action will reduce the pathway forenergy production via Kerb's cycle (the cycle of oxidation of food toobtain energy with production of many free radicals). Free radicals arebelieved to be the most important factor in acceleration of the agingprocess by oxidative damaging the vital structures of human proteins.Therefore, NIR reduces the production of free radicals so it isindirectly considered as antioxidants. NIR also tends to increaseprotein synthesis. In particular, NIR is absorbed by the chromosomeswhich are present as double helix DNA. Recent studies show that NIRcauses double helix DNA to be in unwound position and this willfacilitate new protein synthesis because translation of proteins needsdouble helix DNA to be in an unwound state. This also saves energyneeded at the cellular level for unwinding the double helix DNA.

Externally applied NIR is successfully used in treatment of chronicarthritis, tendinitis, synovitis, bursitis, etc. The mechanism of actionfor treatment of chronic pain by NIR is by local increase of bloodsupply, which accelerates the healing process and removes the mediatorsresponsible for pain by washing them out to blood stream. Activation ofnearby dormant MSCs may also serve to repair the damaged tissues by themechanism similar to stem cells injection. The increased blood supplymay also increase immune cells to clean tissue debris, which delayshealing process and break down later to form pain mediators.

NIR is absorbed by hemoglobin inside red blood cells (RBCs). Nomitochondria are found in RBCs so the energy necessary for theirmaintenance is obtained only by glycolysis (anaerobic oxidation ofglucose with lactic acid production). Recent studies show that NIR hasenergy that could be utilized by RBCs for their maintenance, especiallyfor cell membrane vitality via the sodium/potassium pump mechanism.Since RBCs are responsible for carrying oxygen from the lungs to tissuesthen carrying carbon dioxide from tissues back to the lung theirincreased vitality should enhance local peripheral tissue oxygenation.

It should be pointed out at this juncture that practically speaking allIR lasers are not pure NIR or FIR. Rather, they are typically of mixedwavelengths, with different percentages of the mixture. Therefore, allthe above benefits of FIR and NIR are present together and they arecalled the molecular benefits of infra-red because they happen insidethe cells.

Infra-red laser therapy both (FIR and NIR) have the problem that about50% are lost in the skin barrier. Even the remaining 50% graduallybecome weaker and weaker while they are travelling away from the skinuntil they become completely lost.

Turning now to FIG. 1 it can be seen that the device 20 basicallycomprises a housing 22 and a needle 24. The housing is a hollow memberin which an IR laser source 26 (FIG. 2) of any conventional constructionis located. The housing is of any suitable shape and size to enable itto be readily held in the hand of a physician or other health careprovider. In the exemplary embodiment it is of cylindrical shape and hasa distal end wall 28 including an externally threaded, hollow connector30 (FIG. 2). The connector 30 is arranged to be releasably secured to aconnector forming a portion of the needle 24 to mount the needle on thehousing. In particular, the needle 24 is an elongated hollow linearmember having an enlarged hollow hub or connector 32 at its proximalend. The connector 32 is internally threaded to mate with the externalthreads of the connector 30 of the housing 22. A passageway 34 ofcircular cross-section extends from the hollow interior of the connector32 to the distal end 36 of the needle. The distal end 36 of the needleis open and is sharpened, e.g., cut or beveled an acute angle. Thus, theentire length of the passageway 34 from the proximal end of the needleto the open distal end is unobstructed. The IR source 26 is arranged toproduce a collimated IR laser beam 38 at an outlet port (not shown)located within the housing 22 at the proximal end thereof and disposedimmediately adjacent the hollow interior of the threaded connector 30.An ON/OFF switch or button 40 is located on the housing 22 and coupledto the laser source 26. The laser source 26 is arranged to be activatedto produce the IR laser beam 38 upon depressing or moving the button 40to the ON position. Accordingly, when the needle 24 is mounted on thehousing and the IR laser beam 38 is produced the IR laser beam exits thesharpened distal end 36 of the needle.

The needle 24 is arranged to be manipulated by manipulating the housingso that the needle pierces the skin and underlying anatomictissue/structures of a patient to bring the open distal end 36 of theneedle to a position closely adjacent some deep tissue/structure whichforms the region to be irradiated by the IR laser beam (hereinaftercalled the “region of interest”). Thus, a clear and unobstructedpassageway from the laser source to the region of interest results forthe laser beam to traverse un-attenuated by the intervening skin,subcutaneous tissue, muscle and any other anatomic tissue/structure(s).

In accordance with one preferred exemplary embodiment of this inventionthe needle 24 is relatively long, e.g., 3 to 4 inches and of a largegauge (wide bore caliber), such as 14 G or wider, depending upon thedisease/condition to be treated and the location of the region ofinterest. The sharpened or beveled tip 36 of the needle facilitates itspassage through the skin and intervening anatomic tissue/structures tothe region of interest. If desired, smaller caliber needles may also beused with a medical device constructed in accordance with the subjectinvention. Such an alternative device may make use of a laser sourcecapable of producing a smaller caliber beam, e.g., a Nano-laser. Withsuch smaller caliber laser instruments, the process of may be carriedout without the need for anesthesia, since a smaller caliber needle isless traumatic.

Use of the IR laser device 20 to bring the un-attenuated IR laser beamto the region of interest, e.g., the deep tissue/structure, isaccomplished in a similar manner to the injection of fluids into thebody of a patient via a conventional needle or syringe. To that end, thedevice 20 is used by first scraping the skin of the patient with anantiseptic solution, as in case of injection by ordinary fluid-injectingsyringe. It is preferable to apply a topical skin anaesthetic for thoseuse applications wherein the needle 24 is of a particularly large gaugeor wide bore caliber needle to avoid patient discomfort. The hub orconnector 32 of the appropriate sized needle 24 is then threadedlyengaged onto the connector 30 at the distal end of the housing, so thatthe port of the laser source from which the IR laser beam 38 emanates isin communication with the proximally located entry to the hollowinterior or passageway 34 extending through the needle. Once the needleis secured to the housing, its sharpened distal end 36 can be broughtinto engagement with the skin of the patient overlying the region ofinterest to be irradiated with the laser beam, e.g., the diseased situs.The device 20 can then be pushed forward to introduce the needle throughthe skin, and the underlying tissue/anatomic structure(s) so that thesharpened free distal end of the needle is closely adjacent the regionof interest. The ON/OFF button 40 on the device can then be depressed tocause the laser source 24 to produce the IR laser beam 38. That beampasses through the passageway 34 of the needle and out of the opendistal end so that the exiting beam is at full potency where it exitsand is un-attenuated by the intervening skin, subcutaneous and musclebarriers. Moreover, being a collimated beam, the exiting IR laser can befocused onto the region of interest to irradiate the tissue/structure atthat region. That beam will be reflected and scattered as a result ofits impingement on the tissue/structure at the region of interest to aproduce what can be called an IR diffusion zone. The IR diffusion zoneis shown schematically by the multiple dots designated by the referencenumber 42 (FIGS. 3-13). The laser device 20 can be manipulated to movethe distal end of the needle to any desired position to increase and/orshape the distraction zone to spread the IR radiation throughout thewhole region of interest. For example, as will be described later, incase of treating arthritis in the knee joint, the needle can be insertedin the knee joint and then manipulated to spread the IR laser radiationto most of articular cartilage.

Turning now to FIGS. 3-13 there are shown various uses of a laser device20, like that disclosed above. It should be pointed out that the othertypes of IR laser devices, than the exemplary embodiment shown in FIG.1, can be used for the various methods, providing that whatever laserdevice is used, it makes use of a needle arranged to pierce through theskin and underlying tissue/structures to a position closely adjacent theregion of interest to bring an un-attenuated IR laser beam thereto.Thus, the subject invention enables the treatment of deep seatedstructures, which heretofore were able to receive only a very littlepercentage of externally applied pulsed IF laser radiation because 50%of the laser beam was lost in the skin barrier and the remaining 50%gradually lost as the beam passes from the skin to the underlying tissueto a maximum of approximately three inches at which virtually all of theenergy is lost. In contradistinction, with the subject invention'sability to deliver an un-attenuated IR laser beam to deep seatedtissue/structure, five common advantages are achieved and repeated withIR utilization in every disease process. Those five common advantagesare as follows. The local heat produced by the IR laser beam shouldincrease the local blood supply with increased tissue oxygenation ofischemic deep structure, thereby reversing the disease process.Moreover, the increased blood supply should have a washing effect inremoving of mediators responsible for pain. The laser beam shouldeffectuate the local increase of immune cells to clean up of tissuedebris (devitalized tissues) that otherwise impede the healing process.The laser beam should also stimulate dormant MSCs and effect theunwinding of double helix DNA, thereby increasing protein synthesis toaccelerate the healing process. All of those five common effects arerepeated in every disease process with some variations according to thedepth of situs, the severity of the disease process, the blood supply ofarea surrounding the site of interest. The foregoing five common effectsof the IR laser will be discussed with each disease process for whichthe subject invention has utility.

FIG. 3 is an illustration of the exemplary infra-red laser device 20 ofFIG. 1 shown in the process of treating a non-union or delayed unionbone fracture by directing the IR laser beam 38 thereto in accordancewith one exemplary method of this invention. In this example the femur44 is fractured at 46. The skin of the patient's leg is designated bythe reference number 48 and the thick thigh muscles are designated bythe reference number 50. The needle 24 with its free end is introducedthrough the skin and intervening thigh muscles to a position closelyadjacent the fracture 46. The laser device is then operated by the userpressing the ON/OFF button to the ON position, whereupon the IR laserbeam is produced and exits the open free end of the needle to result inthe distribution of the IR energy throughout the diffusion zone 42 sothat it is at a maximum in the region of interest, e.g., the regionalong the bone portions contiguous with the fracture. This applicationof pulsed IF laser therapy for treatment of bone fracture with delayedunion and non-union offers promising results by accelerating the healingprocess so it can be used as an important core therapy not only as anadjuvant therapy. The higher IR dose being provided by the device 20stimulates MSCs, which should lead to new bone formation. Excess proteinsynthesis by DNA stimulation will synthesize much collagen protein whichconstitutes about 28% of bone mass. Moreover, the increased blood supplyengendered by the IR radiation should accelerate the healing processbecause the immune system will clean the intervening soft tissue debristhat may interfere with healing process. Lastly, the increased bloodsupply promotes local tissue oxygenation necessary for reconstruction ofnew bone.

FIG. 4 is an illustration of the exemplary infra-red laser device ofFIG. 1 in the process of treating avascular necrosis (AVN) of the head52 of the femur 44 by directing the IR laser beam 38 thereto inaccordance with another exemplary method of this invention. To that end,the needle 24 with its free end is introduced through the skin andintervening thigh muscles to a position closely adjacent the situs ofthe AVN at the femur head 52. The laser device is then operated by theuser pressing the ON/OFF button to the ON position, whereupon the IRlaser beam is produced and exits the open free end of the needle toresult in the distribution of the IR energy throughout the diffusionzone 42 so that it is at a maximum in the region of interest, e.g., theregion encompassed by the AVN. Since AVN disease is characterized byischemia (reduction of blood supply) of part of the bone leading to adevitalized tissue formation in the affected segment, the irradiation ofthe AVN region with the IR laser (which can reach the deep seateddisease to stimulate and increase the blood supply thereat) shouldprovide superior results than prior art IR laser techniques. Moreover, alarger amount of energy that the device and method of this invention iscapable of providing should effect sufficient stimulation of MSCs toexpedite the repair the ischaemic area with new bone formation.Furthermore, the increase blood supply plus the better tissueoxygenation via increased RBCs vitality act as accessory factors foraccelerated healing of AVN. Lastly, the immune cells can invade the areaand clean the devitalized tissues debris.

FIG. 5 is an illustration of the exemplary infra-red laser device ofFIG. 1 in the process of treating chronic low back pain by directing theinfra-red laser beam to the facet joints, the back of the vertebralbodies and intervening discs of the spine in accordance with anotherexemplary method of this invention. Chronic low back pain is a group ofdiseases that affects a large number of the population (e.g.,approximately 25 million in the United States), especially obese elderlywomen. While the results of the prior art treatment with an externallyapplied pulsed IR laser are generally good, they could clearly bebetter. The subject invention provides a greater chance of success intreating this group of diseases because the vertebral body andintervening intervertebral discs are approximately 3-4 inches or morefrom the skin. Therefore, as shown in FIG. 5 the needle 24 is introducedso that its free distal end 36 is located immediately adjacent a facetjoint 54 and the back of vertebral bodies 56 and intervening discs 58,which are the sources of the back pain. At this time the laser device isoperated to produce the IR laser beam 38, which is distributedthroughout the diffusion zone 42 so that it is at a maximum in theregion of interest, e.g., the facet joints, the back of the vertebralbodies and intervening discs of the spine.

A recent published paper asserts that the local heat by laser beam willincrease the blood supply necessary for healing and removal of themediators that are responsible for the pain and also the increased bloodsupply to the compressed nerves, which results in more nutrition tothese compressed spinal nerves. Moreover, the immune cells clean thearea of herniated discs which compress the spinal nerves. Thus,subsequently, the pain will subside. Furthermore, the IR laser increasesthe blood supply to the back muscles leading to their strengthening,which is essential part in protecting lumber discs. Recent studies showthat MSCs around discs and the back of vertebrae can repair the damagedtissues and replace them with new tissues similar to the original ones.Thus the use of the laser device of this invention may provide benefitsakin to that of a stem cell injection.

FIG. 6 is an illustration of the device shown in FIG. 1 in the processof treating plantar fasciitis in accordance with another exemplarymethod of this invention. In FIG. 6, the plantar fascia 56, which is aligament that spreads from calcaneus 58 under the talus 60, thenavicular 62, the cuneiform 64 and the metatarsals 66 to the toes, isshown with an exemplary tear 68 adjacent the calcaneus 58. Plantarfasciitis is the most common cause of heal pain and affectsapproximately 10 million persons in the United States. Repeatedstretching of the plantar fascia, particularly by overweight persons,causes micro-tears therein. Such tears increase the inflammatory processas a compensatory mechanism to increase the blood supply, which isassociated with painful mediators. As shown in FIG. 6, the laser device20 is used to place the distal end 36 of the needle 24 immediatelyadjacent the tear 68 and the laser beam 38 activated to produce adiffusion zone 42 of IR energy that is at a maximum or concentrated atthe tear. The application of IR energy to the situs of the tear shouldsignificantly increase local blood supply to the plantar fascia thereat,thereby improving recovery and healing. This action overcomes thedisadvantages of the prior art externally applied pulsed IR lasers,because all of the IR laser energy is directed towards the exactlypainful area (the area of micro-tears), without any loss of energy inthe thick skin 70 of the sole and in the subcutaneous tissues 72, whichwould tend to absorb more than 70% of energy if the IR laser beam wasexternally applied like in the prior art.

FIG. 7 is an illustration of the device shown in FIG. 1 in the processof treating osteomyelitis in accordance with another exemplary method ofthis invention. Chronic osteomyelitis (septic bone infection) iscatastrophic disease that is very difficult to treat and a full cure issometimes impossible. It needs a long term course of treatment,sometimes over years with repeated surgical intervention in many cases.With this disease bacteria live in devitalized bone and hence are remotefrom the immune system. Many clinics claim that pulsed IR laser therapyimproves the condition and reduces its course resulting from local heatproduction at the situs of the infection. This heat in turn increasesthe blood supply and raises the immunity by increasing the number ofimmune cells (macrophages and lymphocytes) in the affected devitalizedbone. The skin barrier is very important in this condition because thisdisease needs the application of very high energy to the infectionsitus. The prior art devices for externally applying pulsed IR laserenergy cannot deliver sufficient energy to the infection, which can bethree or more inches below the skin surface, without risking damage tothe skin of the patient. In contradistinction, the subject IR laser canbe used to treat deep seated infections. For example, as shown in FIG. 6the device 20 is shown in the process of treating a chronicosteomyelitis infection 74 within the femur 42 by introducing the freeend 36 of the needle 24 to a position closely adjacent the situs 74 ofthe infection and operating it to produce a diffusion zone 42 of IRenergy at a maximum or concentrated at the infection situs to heat thatsitus. Moreover, the high, focused, and very near IR laser is capable ofstimulation of MSCs to enhance new bone formation (involucurum) toreplace the devitalized one (sequestrum). Therefore, a pulsed IR laserconstructed and used in accordance with this invention can be consideredas an important core method of treatment not only as an adjuvant thatcan modify the course of treatment.

FIG. 8 is an illustration of the device shown in FIG. 1 in the processof treating supra-spinatus tendonitis in accordance with anotherexemplary method of this invention. Supra-spinatus tendinitis (alsoknown as rotator cuff tear or impingement syndrome) is a condition thatmay start by ischemia of the supra-spinatus tendon and which will bepresented as swelling of that tendon as a compensatory mechanism toenhance the blood supply. The problem is that the supra-spinatus tendon76, which connects the supra-spinatus muscle 78 to the head of thehumerus 80, is located inside a confined space between the head ofhumerus, the acromion bone 82 and the deltoid muscle 84. Thus, theswollen tendon will not be allowed to expand so that the pressure isincreased, thereby aggravating the cycle of ischemia because of the highpressure compressing the blood vessels further. It has been determinedthat pulsed IR laser therapy improves the blood supply by the localheat, with absorption of excess fluids, so it reverses the whole diseaseprocess. Moreover, this local increase of blood supply helps in recoveryof the tendon with removal of the mediators responsible for pain. Tothat end, as shown in FIG. 8 the IR laser device 20 of this inventioncan be used to treat this condition by introducing the free end 36 ofthe needle 24 through the thick deltoid muscle to a position closelyadjacent the supra-spinatus tendon 76 and operating it to produce adiffusion zone 42 of IR energy at a maximum or concentrated thereat toheat the tendon. Thus, the laser device of the subject invention and itsmethod of use is superior to the prior art because it transmits the IRlaser energy directly near to supra-spinatus tendon without loss of anypart of it in the skin, subcutaneous tissue or the very thick deltoidmuscle. Because the subject invention can transmit a very large amountof IR laser energy very near to the tendon, it should stimulate MSCsthat can repair some of the devitalized area of the tendon and replacethem with new tendon substance. Moreover, the IR laser energy shouldassist in the unwinding of double helix DNA to stimulate new collagenprotein synthesis which constitutes 50% of the substance of the tendonmaterials.

FIG. 9 is an illustration of the device shown in FIG. 1 in the processof treating patello-femoral maltracking in accordance with anotherexemplary method of this invention. Patellofemoral maltracking is themost common cause of anterior knee pain. There is a new theory of thisparticular disease process that is a result of extensive studies in theUnited States. The new theory is called “tissue homeostasis theory” andclaims that the starting point is ischemia of the lateral retinaculum ofthe patella which contracts with subsequent neural tissue infiltrationin the lateral retinaculum. The contracted lateral retinaculum pulls thepatella laterally resulting in lateral tilt of the patella withsubsequent damage of patellar cartilage by high friction of the patellarcartilage with uneven maltrack. The damaged patellar cartilage causessevere pain with each flexion-extension of the knee. Prior art pulsed IRlaser therapy can improve the condition by its application to anteriorpart of knee, which will increase the blood supply to the ischemic areaand washing the pain mediators. However, such action is not effective inregeneration of damaged patellar cartilage which is the main source ofpain. As shown in FIG. 9. the laser device 20 of this invention can beused to treat this condition by introducing the free end 36 of theneedle 24 through the skin 48 and the lower pole 86 of the patellar bone88 (and possibly the patellar tendon 90) to the articular cartilage 92.The articular cartilage 92 is interposed between patellar bone 88 andthe femur condyle 94 adjacent the quadriceps muscle 96. Since the needlewill have to pass through the lower pole of the patella (hard bone asopposed to soft tissue), anesthesia will likely be required. The IRlaser device 20 can then be activated to produce the laser beam 38 toproduce a diffusion zone 42 of IR energy at a maximum or concentrated atthe articular cartilage, which is very difficult to be reached by theprior art because of skin, subcutaneous tissues, and patellar bonebarriers. The IR laser produced by the subject invention and directed tothe region of interest helps in regeneration of the patellar cartilageby stimulating chondrocytes to repair the damaged cartilage. IR laseralso stimulates the MSCs in cartilage stoma to produce more chondrocytesto synthesize more new cartilage. This technique is exemplary inrepairing the actual cause of pain, which is the damaged patellarcartilage plus the initiating factor of lateral retinacular ischaemiabecause the diffusion zone of radiation reaches these sites by goodconcentration without barriers.

FIG. 10 is an illustration of the laser device 20 of FIG. 1 shown in theprocess of treating coccydynia in accordance with another exemplarymethod of this invention. Coccydynia is pain at lowest part of thespinal column. It is of unknown cause, but most probably it is due toinjury of sacrococcygeal ligament. It is more common in women aftergiving birth and occurs to lesser extent in males. It is difficult andrefractory to treat and there is a great deal of individual variationsin response to treatment. Sometimes, even surgical excision may not behelpful.

Many clinics in the United States and Canada have claimed that pulsed IRlaser therapy has an excellent response, especially in cases which havepoorly responded to other medical treatments. However, getting the IRlaser to a deep seated situs where this condition typically resides canbe problematic. The IR laser device of this invention offers asignificant modality for treating coccydynia irrespective of the depthof the sacro-coccygeal joint from the skin. To that end, as can be seenin FIG. 10 the laser device 20 is used by introducing the free end 36 ofthe needle 24 through the skin 48 and the subcutaneous tissue (thickfat) 98 to a position closely adjacent the sacro-coccygeal joint 100 ofthe sacrum 102. The IR laser device can then be activated to produce thelaser beam 38 to produce a diffusion zone 42 of IR energy at a maximumor concentrated at the sacro-coccygeal joint 100 to heat it. As with theother methods described above, the subject invention concentrates IRlaser energy at the painful sites so there would be a higher incidenceof improvement than with a conventional externally applied pulsed IRlaser. The increase blood supply helps rapid healing of damaged tissueand washing out the mediators that are responsible for pain. Theincreased blood supply also enhances more immune cells to invade thezone of diffusion clearing all tissue debris that delay healing.

FIG. 11 is an illustration of the device shown in FIG. 1 in the processof treating carpal tunnel syndrome in accordance with another exemplarymethod of this invention. Carpal tunnel syndrome is a diseasecharacterized by oedema fluid collection and swelling in the soft tissueof the flexor compartment of the hand in front of the carpus bone 106.The transverse carpal ligament 108, which is located on the palmar side110 of the hand will be tightened by oedema fluid and subsequently willcompress the median nerve 112 (which is located adjacent the flexortendons 114). Pulsed IR laser treatment helps to increase the bloodsupply, which will lead to absorption of oedema fluid. The prior art isless efficient because the diffusion zone of IR is mostly absorbed byskin, subcutaneous tissues and thick transverse carpal ligament. Veryminimal IR laser energy can cross all these barriers. To that end, ascan be seen in FIG. 11 the laser device 20 is used by introducing thefree end 36 of the needle 24 through the skin 48 and the subcutaneoustissue to a position just under the transverse carpal ligament 108 andabove the median nerve 112. The IR laser device can then be activated toproduce the laser beam 38 to produce a diffusion zone or region 42 of IRenergy at a maximum or concentrated at that region to heat it. As withthe other methods described above, the subject invention concentrates IRlaser energy at the painful sites so there would be a higher incidenceof improvement than with a conventional externally applied pulsed IRlaser. The increase blood supply helps rapid healing of damaged tissuesand removes the mediators that are responsible for pain plus absorptionof oedema fluids leading to pain subsidence. In addition, recent studiesshow that laser therapy increases formation of elastic fibers fromnearby MSCs. This will cause the transverse carpal ligament to becomemore elastic and relaxes with much improvement of the condition ofcarpal tunnel.

FIG. 12 is an illustration of the device shown in FIG. 1 in the processof treating osteo-arthritic joint disease (e.g., the tibia-femur jointof the knee) in accordance with another exemplary method of thisinvention. Osteo-arthritic joint diseases are degenerative jointdiseases which break down the articular cartilage which become thin,eroded, and sometimes ulcerated with reduction lubricant materials(e.g., synovial fluids) leading to painful movements. Pain of mild tomoderate arthritis can be improved by prior art pulsed IR laser therapy.The mechanism of action is by local increase of the blood supply to thejoint and surrounding muscles. The increase of local blood supply shouldlead to stimulation of the lubricant materials. It should also stimulatehealing of the ulcers and facilitate washing of the mediators that areresponsible for pain. Moreover, IR enhances the immune cells to clearall tissue debris that are always associated with osteo-arthritis. Thiscan be applied to any joint, but clinically this method is used in thehip and knee joints. The IR laser devices of the subject inventionprovide a more viable means for achieving that end. In particular, asshown in FIG. 12 the laser device 20 is used by introducing the free end36 of the needle 24 through the skin 48, through the subcutaneous tissueand through the patellar tendon 90 to the articular cartilage 116between the femur 80 and the tibia 118. The IR laser device can then beactivated to produce the laser beam 38 to produce a diffusion zone orregion 42 of IR energy at a maximum or concentrated at the articularcartilage 116 to heat it and produces all the above benefits much morethan that of the prior art because of the higher dose of IR.

FIG. 13 is an illustration of the device shown in FIG. 1 in the processof reducing abdominal fat and visceral fat in accordance with anotherexemplary method of this invention. While this methodology is not purelyorthopedic in nature, it still constitutes part of this invention fortwo main reasons. First, a reduction of abdominal fat will greatlyreduce the mechanical stresses on the joints of the lumbar spine, thepelvis, and the lower limbs. In other words, the reduction of abdominalfat helps to protect the joints of spine, pelvis and lower limbs. Thesecond reason is considered as a prophylactic measure to preventorthopedic problems before their occurrence. In this regard, the methodof FIG. 13 is a preventive one to avoid orthopedic diseases,particularly since a significant number of orthopedic diseases occur inold and debilitated persons. Thus, with the subject invention the IRlaser when used on abdominal fat serves to activate the deep seated stemcells and repair damaged tissues, including the orthopedic system, e.g.,repairing joint cartilage which tends to prevent or delay the progressof osteo-arthritis, repair ischaemic tendon to avoid tear, stimulationof bone cells to synthesize new bone formation to avoid fracture and soon.

To accomplish the reduction of abdominal fat the free end 36 of theneedle 24 of the IR laser device 20 is inserted through the skin throughthe subcutaneous tissue and into the abdominal fat 118 at any desiredposition therein. The IR laser device can then be activated to producethe laser beam 38 to produce a diffusion zone or region 42 of IR energyat a maximum or concentrated within that fat to heat it and therebyactivate its stem cells. The diffusion zone can cross the thin andstretched abdominal muscles 122 to reach the underlying deeper visceralfat 124 overlying the abdominal viscera 126, a function unavailablethrough the use of prior art externally applied IR lasers.

As should be appreciated by those skilled in the art from the foregoingthe subject invention offers numerous advantages over the conventionalpulsed IR laser therapy. In particular, the subject invention by-passesthe skin barrier and allows penetration to deeper tissues/structures,e.g., three inches or greater. In fact devices constructed in accordancewith this invention and their methods of use can apply IR energy at anydepth within the body of the patient by the selection of an appropriatesized needle. Since the skin and underlying tissue is by-passed, an IRlaser, e.g., a pulsed IR laser, constructed in accordance with thisinvention can apply maximum energy to the region of interest withoutfear of skin damage. Moreover, the IR beam can be precisely directed tothe region of interest by merely orienting the needle in the desireddirection and to the desired depth, thereby by-passing all unnecessarytissue barriers.

The devices and methods can be used to treat internal structures, e.g.,muscles, tendons, ligaments, cartilage, bones, and/or joints, with IRlaser beams in the range of 200 mW to 500 mW, with the dosage beingadjustable and based on conditions and the application desired. Forexample, in the case of osteomyelitis, the laser can be 500 mW.Moreover, the IR laser source can be arranged to produce a nearinfra-red laser beam in the range of approximately 0.7 μm to 3.0 μm or afar infra-red laser beam in the range of approximately 50 μm to 1000 μm,again according to conditions and the application desired.

Without further elaboration the foregoing will so fully illustrate ourinvention that others may, by applying current or future knowledge,adopt the same for use under various conditions of service.

We claim:
 1. A method of treating an orthopedic disease or condition ofa patient by the irradiation of an orthopedic region of interest locatedwithin the body of the patient, said orthopedic region of interest beingbone, cartilage adjacent bone, tendons adjacent bone or ligamentsadjacent bone, said method comprising: a) providing a device comprisinga housing and a needle, said needle being an elongated member having aproximal end, a sharpened distal end and a hollow passageway extendingtherethrough from said proximal end to said distal end, said housingcomprising an infra-red laser source located therein arranged whenactivated to produce a collimated infra-red laser beam to enter intosaid hollow passageway at said proximal end of said needle and passtherethrough to exit said distal end of said needle; b) introducing saidneedle into the body of the patient by causing said sharpened distal endto pierce skin and underlying tissue so that said distal end of saidneedle is positioned closely adjacent said orthopedic region ofinterest; and c) activating said laser source to produce a nearinfra-red laser beam having a wavelength in the range of 0.7 μm to 3.0μm and an energy in the range of 200 mW-500 mW to heal or repair saidorthopedic region of interest, wherein said infra-red laser beam exitssaid distal end of said needle to directly deliver said infra-red laserbeam to said orthopedic region of interest without intervening skin andunderlying tissue attenuating said infra-red laser beam.
 2. The methodof claim 1 wherein said infra-red laser source produces a continuousinfra-red laser beam.
 3. The method of claim 1 wherein said infra-redlaser source produces a pulsed infra-red laser beam.
 4. The method ofclaim 1 wherein said orthopedic disease or condition is a non-union ordelayed-union bone fracture.
 5. The method of claim 1 wherein saidorthopedic disease or condition is avascular necrosis.
 6. The method ofclaim 1 wherein said orthopedic disease or condition is low back pain.7. The method of claim 1 wherein said orthopedic disease or condition isplantar fasciitis.
 8. The method of claim 1 wherein said orthopedicdisease or condition is osteomyelitis.
 9. The method of claim 1 whereinsaid orthopedic disease or condition is supra-spinatus tendinitis. 10.The method of claim 1 wherein said orthopedic disease or condition ispatellofemoral maltracking.
 11. The method of claim 1 wherein saidorthopedic disease or condition is coccydynia.
 12. The method of claim 1wherein said orthopedic disease or condition is osteoarthritic jointdisease.
 13. The method of claim 1 wherein said orthopedic disease orcondition is carpal tunnel syndrome.